Label: ARC SKIN PROTECTANT- allantoin ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69148-001-00, 69148-001-01 - Packager: Anjon Biologics, Inc
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 1, 2022
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- Official Label (Printer Friendly)
- ARC Skin Protectant Ointment
- Active Ingredient / Purpose
- Use
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Warnings
For external use only
Do not use on
- deep or puncture wounds
- animal bites
- serious burns
When using this product
- do not get into eyes.
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- your skin shows significant sign of irritation or discomfort
- Directions
- Other information
- Inactive Ingredients
- Questions or comments?
- ARC Skin Protectant Ointment 4oz/118.6g (69148-001-00)
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INGREDIENTS AND APPEARANCE
ARC SKIN PROTECTANT
allantoin ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69148-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZOIC ACID (UNII: 8SKN0B0MIM) BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERIN (UNII: PDC6A3C0OX) IMIDUREA (UNII: M629807ATL) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) JOJOBA OIL (UNII: 724GKU717M) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) SORBITAN TRISTEARATE (UNII: 6LUM696811) VITAMIN A (UNII: 81G40H8B0T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69148-001-00 118.6 g in 1 TUBE; Type 0: Not a Combination Product 08/06/2014 2 NDC:69148-001-01 60 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/06/2014 Labeler - Anjon Biologics, Inc (054126951) Registrant - Anjon Biologics, Inc (054126951)